詳細条件から探す

治験業務全般をサポート！直行直帰が可能なCRCへの転職

仕事内容

・医療機関の関係者への説明会の準備と開催
・カルテの中から、治験にご参加頂く患者さまのピックアップ、治験にご参加頂くための同意説明・同意取得の補助
・患者さま（被験者）の来院スケジュール管理
・治験のルールや規則確認
・被験者の服薬状況の確認
・症例報告書（検査データや副作用など情報をとりまとめたもの）の作成補助
・薬剤部門や治験担当医など治験に関わる関連部門との連絡、調整

応募条件

【必須事項】

・CRC経験者は資格不要。

CRC未経験者は以下の医療関連資格者保有者
薬剤師、看護師、准看護師、保健師、臨床検査技師、臨床工学技士、
理学療法士、診療放射線技師、臨床心理士、管理栄養士、MR

【歓迎経験】

【免許・資格】

【勤務開始日】

応相談

勤務地

【住所】 全国、愛知、他

年収・給与

400万円～550万円　

大手内資製薬メーカーにてオンサイトサポートエンジニアを募集しています。

仕事内容

Onsite Support:
• Provide timely and effective technical support for hardware, software, and networking issues.
• Perform routine maintenance, （For Senior position :）windows patching and upgrades on IT systems and equipment. (Computers, servers, operating systems, networks, and other technology components.)
• Install and configure computer systems, iPads, iPhones, printers, and other peripherals.
• For Senior position : Be the point of escalation.
Troubleshooting and Repair:
• Diagnose and resolve technical issues with computers, servers, networks, and other technology components.
• Perform hardware repairs, replacements, and system updates as needed.
• Utilize diagnostic tools and software to identify and address system faults.

Customer Service:
• Provide exceptional customer service to clients by addressing their technology concerns promptly and professionally.
• Communicate effectively with clients to understand their needs and provide appropriate solutions.
• Train and support end-users on technology usage and best practices.
Documentation and Reporting:
• Maintain accurate records of all onsite activities, including service requests, incident reports, and maintenance logs.
• Document configurations, procedures, and troubleshooting steps for future reference.
• Provide regular status updates and reports to management.
Compliance and Security:
• Ensure compliance with company policies, industry standards, and regulatory requirements.
• Implement and enforce security protocols to protect client data and IT infrastructure
• Continuous Improvement:
• Stay current with emerging technologies and industry trends.
• Participate in training and professional development opportunities to enhance skills and knowledge.
• Contribute to the development and implementation of best practices and process improvements.

Work as one team:
• Work together with counterparts within and between the sites to share knowledge and improve processes
• Work together with other support teams which are on-site. (e.g Lab support , AV support)
• Work together with remote teams to provide the best possible service. (e.g Infrastructure , Security)
• Be the hands and eyes for remote teams when needed. (e.g. Network , Server , Security team)

応募条件

【必須事項】

• Bachelor’s degree in Computer Science, Information Technology, or related field, or equivalent experience.
• 3+ years, for Senior position 5+years, of experience in a field services or similar technical support role.
• For Senior position :3+ years of experience in manufacture or research environments
• Strong knowledge of computer hardware, software, networking, and operating systems.
• Proficiency in troubleshooting and repair of IT equipment and systems.
• Excellent customer service and communication skills.
• Ability to work independently and manage multiple tasks effectively.
• Fluent in written and verbal business Japanese
• Some knowledge of pharmaceutical business and related business processes
• Some experience with IT Service Management, Service Desk, and Change Management processes
• Some work experience across multiple cultures and countries / regions is a plus
• Knowledge of ITIL and Agile
• Knowledge of ServiceNow ITSM
• Appreciation of working cultures and countries / regions
• Willingness to travel to other sites as required.

【歓迎経験】

• Certifications such as CompTIA A+, Network+, or Microsoft Certified .
• Familiarity with Microsoft products (e.g., Teams, OneDrive, M365, Server Operating systems, Azure).
• ITIL and/or Agile certifications
• For Senior position :Advanced knowledge of ServiceNow ITSM (e.g. reporting, monitoring)
• Fluent in written and verbal business English

【免許・資格】

【勤務開始日】

応相談

勤務地

【住所】富山

年収・給与

800万円～　経験により応相談

SMOにて提携医療機関数の拡大および提携医療機関とのリレーションを強化

仕事内容

即戦力となるＳＭＡ（治験事務局担当者）を募集いたします。

治験をスムーズに実施できるよう、医師や治験依頼者（製薬会社等）の窓口となり、
既存施設への案件打診・アンケート回収、新規開拓をご担当頂きます。
また、医師や関連部門のアポイント取得等の院内調整、契約書の作成や管理、
ＩＲＢの申請手続きなどの業務をご担当頂きます。

応募条件

【必須事項】

・SMA経験者は不問。
・未経験者は資格は問いませんが、営業経験が必須となります。

【福岡】
・営業経験がある方もしくは医療機関での勤務経験がある方

【歓迎経験】

医療業界でのご経験であれば尚可

【免許・資格】

【勤務開始日】

応相談

勤務地

【住所】福岡、他

年収・給与

450万円～550万円　

漢方薬原料のパイオニアであり、トップシェアを誇るメーカーにて提案営業

仕事内容

医薬品メーカー、漢方薬メーカー、健康食品メーカーなどの購買部門、開発部門、研究所への営業活動を行っていただきます。素材の仕入れから製品の販売まで一貫して担当致しますので、顧客ニーズを速やかに回収し、1000種類以上の商品群から顧客に最適な提案をしていただく提案営業を行っていただきます。

※日本各地の製薬メーカー、食品メーカー、化粧品メーカーの購買部門、研究・開発部門への訪問を行いますので出張が発生致します。（平均2～3回/週）
※素材の主産地である中国へ出張を行うこともございます。

応募条件

【必須事項】

・理系学部・学科のバックグラウンドをお持ちの方
・英語もしくは中国語のできる方

【歓迎経験】

・製薬メーカーの研究所・開発部門への営業経験をお持ちの方（※医薬品原薬・生薬など）
・応用化学、農芸化学、薬学系の学科をご卒業されている方

【免許・資格】

・普通自動車第一種免許をお持ちの方（必須）

【勤務開始日】

応相談

勤務地

【住所】大阪

年収・給与

300万円～500万円　

大手内資製薬メーカーにてデジタル関連の契約スペシャリストを募集しています。

仕事内容

（雇入れ直後）
• Contract Negotiation: Lead the negotiation of contracts for software and hardware, ensuring favorable terms and conditions that align with company’s objectives. Partner with IS Business Stakeholders, Vendors, Legal, Procurement, and Compliance teams to reach consensus on contract terms, ensuring alignment with company policies and regulatory requirements.
• Contract Management: Oversee the entire contract lifecycle, from drafting and execution to renewal and termination, using enterprise tools such as ServiceNow, Ariba, and Aravo.
• Requirements Gathering: Work with DigitalX stakeholders to ensure requirements are adequately documented and shared with vendors.
• Vendor Relationship Management: Build and maintain strong relationships with vendors and service providers, addressing any issues or concerns that may arise.
• Team Development: Work with junior members of DigitalX Contracting team to provide guidance on specific contracts, develop their skills, and foster a team environment.
• Risk Assessment: Identify and assess risks associated with contracts and develop strategies to mitigate them.
• Collaboration: Work closely with cross-functional teams, including DigitalX, Procurement, and Legal, to ensure alignment on contract scope, terms, and service delivery.
• Performance Monitoring: Monitor vendor performance against contract terms and service level agreements (SLAs), ensuring compliance and addressing any discrepancies.
• Documentation and Reporting: Maintain accurate records of contracts and related documentation and provide regular reports to management on contract status and performance. Monitor contract timelines for renewals, amendments, and terminations.
• Procure-to-Pay Support: Support Procure-to-Pay processes, including Purchase Order creation/changes and resolution of accounting issues (e.g., funding limits, incorrect coding, etc.).
• Policy Development: Contribute to the development and implementation of policies and procedures related to contract management and vendor relationships.

応募条件

【必須事項】

• Degree in Business Administration, Information Technology, Law, or a related field.
• 5+ years of experience negotiating, executing, and managing software and hardware contracts.
• 5+ years of experience managing relationships with vendors, with a strong understanding of vendor governance structure, processes, and best practices.
• Familiarity with different software licensing models.
• Strong negotiation skills
• Strong communication and interpersonal skills, with the ability to build relationships at all levels of the organization.
• Familiarity with relevant legal and regulatory requirements related to IT contracts.
• Proficiency in Microsoft Office tools.
• High-level of Japanese language proficiency, both written and spoken
• High-level of written English language proficiency, intermediate level of spoken English.

【歓迎経験】

• Advanced Degree.
• Consulting Experience.
• CSAM Certification (Certified Software Asset Manager).
• Experience working in the Pharmaceutical or other highly regulated industry.
• Experience with Software Asset Management tools (e.g. ServiceNow SAM Pro, SNOW, etc.)
• Experience with ServiceNow, SAP, and data analytics tools.
• Experience working with contract management software and tools, including Ariba.

【免許・資格】

【勤務開始日】

応相談

勤務地

【住所】東京

年収・給与

800万円～　経験により応相談

大手内資製薬メーカーにて抗体薬物複合体開発のリーダーを募集しています。

仕事内容

（雇入れ直後）
Scientific & Technical Leadership:
-Provide scientific vision, strategic direction, and technical oversight for the Bioconjugation team, ensuring the delivery of well-characterized ADC candidates.
-Collaborate closely with the Antibody Engineering team to define optimal antibody characteristics for conjugation and contribute to the antibody selection strategy for ADC projects
-Lead the design, development, optimization, and execution of novel and established bioconjugation methodologies for creating ADCs, including site-specific conjugation techniques.
-Stay at the forefront of bioconjugation technologies, ADC development, and relevant analytical advancements; evaluate and implement new technologies and approaches to enhance team capabilities and productivity.
-Troubleshoot and resolve complex scientific and technical challenges related to bioconjugation, purification, and characterization

Team Management & Development:
-Lead, manage, mentor, and develop a team, fostering a culture of scientific excellence, innovation, collaboration, urgency, and accountability.
-Ensure appropriate resource allocation, project planning, and timeline management for the Bioconjugation team.

Project & Stakeholder Management:
-Drive bioconjugation aspects of ADC projects from early discovery to development candidate selection, ensuring timely delivery of high-quality data and materials.
-Collaborate effectively with cross-functional teams, including antibody engineering, medicinal chemistry (payload and linker synthesis), analytical development, DMPK, pharmacology, CMC, and external partners.
-Contribute to the preparation of technical reports, patent applications, and regulatory submission documents.

応募条件

【必須事項】

・Ph.D. in Chemistry, Biochemistry, Bioengineering, or a closely related field.
・Minimum of 10 years of experience in the biopharmaceutical industry, with a significant portion focused on
Antibody Drug Conjugate development.
・Proven track record of scientific accomplishment and leadership in the biologics field, evidenced by
publications, patents, and successful advancement of therapeutic candidates.
・Significant hands-on experience and deep understanding of protein chemistry, bioconjugation techniques, and
purification methods for proteins and ADCs.
・Experience in identifying, evaluating, and developing novel technologies.
・Proven ability to think strategically and contribute to R&D portfolio planning.
・Excellent communication, interpersonal, and presentation skills, with the ability to effectively communicate
complex science to diverse audiences.
・Demonstrated ability to work collaboratively in a cross-functional, matrixed environment.
・Minimum of 3 years of experience in leading and managing scientific teams.

【歓迎経験】

・Experience in the development or application of site-specific conjugation technologies
・Knowledge and experience in stability assessment of ADCs, pharmacokinetic (DMPK) characterization, and
in vitro/in vivo efficacy evaluation.
・Experience in the implementation and utilization of high-throughput bioconjugation methods and automation
technologies.
・Knowledge or experience in CMC development of ADCs.

【免許・資格】

【勤務開始日】

応相談

勤務地

【住所】茨城

年収・給与

800万円～　経験により応相談

大手内資製薬メーカーにてシニアの抗体研究者を募集しています。

仕事内容

（雇入れ直後）
Scientific & Technical Leadership:
・Provide scientific vision, strategic direction, and technical oversight for the Bioconjugation team, ensuring the delivery of well-characterized ADC candidates.
・Collaborate closely with the Antibody Engineering team to define optimal antibody characteristics for conjugation and contribute to the antibody selection strategy for ADC projects
・Lead the design, development, optimization, and execution of novel and established bioconjugation methodologies for creating ADCs, including site-specific conjugation techniques.
・Stay at the forefront of bioconjugation technologies, ADC development, and relevant analytical advancements; evaluate and implement new technologies and approaches to enhance team capabilities and productivity.
・Troubleshoot and resolve complex scientific and technical challenges related to bioconjugation, purification, and characterization

Team Management & Development:
・Lead, manage, mentor, and develop a team, fostering a culture of scientific excellence, innovation, collaboration, urgency, and accountability.
・Ensure appropriate resource allocation, project planning, and timeline management for the Bioconjugation team.

Project & Stakeholder Management:
・Drive bioconjugation aspects of ADC projects from early discovery to development candidate selection, ensuring timely delivery of high-quality data and materials.
・Collaborate effectively with cross-functional teams, including antibody engineering, medicinal chemistry (payload and linker synthesis), analytical development, DMPK, pharmacology, CMC, and external partners.
・Contribute to the preparation of technical reports, patent applications, and regulatory submission documents.

応募条件

【必須事項】

•Ph.D. degree with +8~ years’ experience or MS degree with +10~ years’ experience in drug discovery in pharma or biotech
•Deep knowledge and expertise on molecular biology or pharmacology.
•Experience of drug discovery research with cross-functional team.
•Good communication and logical thinking skills that can facilitate the relationship with internal colleagues and external (potential) partners in own language and in English.

【歓迎経験】

•Ph.D. in life science area.
•Experience of drug discovery projects on antibody, especially engineered antibody.
•Experience of pharmacological experiments, especially in vivo animal experiments.
•Experience on collaboration with external partners across multiple scientific disciplines.

【免許・資格】

【勤務開始日】

応相談

勤務地

【住所】茨城

年収・給与

800万円～　経験により応相談

大手内資製薬メーカーにて臨床モニター（CRA）およびサイトマネジメントスタッフ

仕事内容

（雇入れ直後）
Accountable for the identification, onboarding, training and development of monitoring clinical trial talent to support the planning, initiation, execution and close-out of clinical trials with operational excellence. Individuals in this role will also provide leadership/mentorship, in a matrix setting, for activities that support clinical trial teams.
This position is accountable to the Head, Clinical Site Management Early Development, and will provide input into departmental budget and resourcing strategies, including development and implementation of global processes and procedures, non-drug product initiatives, and coaching of monitoring staff during execution of development trials.
·Responsible for resource planning, recruitment, mentoring, development and retention of site monitoring & management staff
·Manage and allocate monitoring resources to trials and monitor performance on assigned trials for monitoring staff (up to 12 direct reports)
·May manage and allocate monitoring resources in more than one region globally
·Provides direction, leadership and learning opportunities to enhance individual development of direct reports in support of providing best-in-class site monitoring across the portfolio
·Provide oversight and guidance in completing monitoring and site management related activities according to agreed timelines and quality standards, including identifying areas for additional training and development
·Oversee adherence to timelines, standards, processes for work assigned to their staff
·Serves as a point of escalation for clinical monitoring/site management related topics or issues from their staff
·Oversee and provide guidance to Clinical Operations Leads and/or Clinical Trial Leads in regional Key Opinion Leader (KOL) interactions, communications; and submissions to Health Authorities within their region/country of responsibility, aligned to the overall asset strategy.
·Responsible for compliance of direct reports with training and identification and support for any training needs
·Facilitate and support global trial monitoring operational standards and tools
·Responsible for resource planning, recruitment, mentoring, development and retention of site monitoring & management staff
·Manage and allocate monitoring resources to trials and monitor performance on assigned trials for monitoring staff (up to 12 direct reports)
·May manage and allocate monitoring resources in more than one region globally
·Provides direction, leadership and learning opportunities to enhance individual development of direct reports in support of providing best-in-class site monitoring across the portfolio
·Provide oversight and guidance in completing monitoring and site management related activities according to agreed timelines and quality standards, including identifying areas for additional training and development
·Oversee adherence to timelines, standards, processes for work assigned to their staff
·Serves as a point of escalation for clinical monitoring/site management related topics or issues from their staff
·Oversee and provide guidance to Clinical Operations Leads and/or Clinical Trial Leads in regional Key Opinion Leader (KOL) interactions, communications; and submissions to Health Authorities within their region/country of responsibility, aligned to the overall asset strategy.
·Responsible for compliance of direct reports with training and identification and support for any training needs
·Facilitate and support global trial monitoring operational standards and tools
·Anticipates, recognizes and facilitates problem solving to support site monitoring & management staff and rapidly addresses and mitigates potential performance issues
·Collaborates effectively with Portfolio Operations Leads, Clinical Operations Leads and SORD leadership to ensure site monitoring & management staff are delivering as expected and to ensure common framework and standards across clinical programs and trials
·Ability to collaborate with peers in Clinical Operations across Early and Late-Stage Clinical Operations, cross-functionally and regionally, including relevant counterparts globally, to align on best practices for clinical monitoring staff
·May lead process improvements relevant to clinical trial monitoring and site management
·Contribute to development and implementation of best-in-class monitoring/site management standards and processes

応募条件

【必須事項】

·BA/BS degree with at least 10 years of executing global drug development programs and trials
·Minimum of 7 years site monitoring and direct people management experience
·Demonstrated leadership skills and ability to effectively collaborate with colleagues in Clinical Operations and cross-functionally to deliver on portfolio deliverables and objectives
·Must have extensive expertise in risk-based monitoring strategies and strong knowledge of ICH/ GCP guidelines and multinational clinical trial regulations
·Must have experience working across multiple phases of development and in multiple therapeutic areas
·Demonstrated ability to successfully identify and lead global process or system improvement initiatives
·Must have a strong knowledge of clinical development processes and conducting global clinical programs
·Must have proven leadership skills and effective written and verbal communication skills
·Fluent in English. Depending on hiring region, may also be required to be fluent in local language.
·Moderate (~30%) travel required

【歓迎経験】

·Advanced Degree

【免許・資格】

【勤務開始日】

応相談

勤務地

【住所】在宅可、東京

年収・給与

800万円～　経験により応相談

結晶関連技術の専門性をお持ちで、将来的に結晶チームを牽引いただける方を募集します。

仕事内容

・ 医薬品原薬・中間体の結晶化とプロセス開発および技術戦略の立案
・ 結晶多形のスクリーニング・評価・制御および研究開発のマネジメント
・ 原薬の塩・共結晶のスクリーニング・評価・制御および研究開発のマネジメント
・ 結晶構造解析および研究開発のマネジメント
・ 若手研究者の指導およびチーム運営
・ 他部門（製剤、分析）との連携によるCMC開発の推進
・ 顧客との技術折衝および受託案件のプロジェクトマネジメント
・ 中長期的な技術開発テーマの企画・推進

応募条件

【必須事項】

・ 理系大学卒以上（薬学、化学、材料工学など）
・ 医薬品または化学品の結晶化研究経験（3年以上）
・ リーダーや管理職としてメンバーのプロジェクトマネジメントの経験
・ チームでの研究推進経験とコミュニケーション能力
・結晶化研究を経験

【歓迎経験】

・ 結晶化の経験と基礎知識
・ 結晶多形や塩・共結晶の評価・管理経験
・ 単結晶X線構造解析を用いた構造解析の経験および結晶学の基礎知識
・ 英語での技術文書の読解・作成経験および海外顧客・関係者との会議を含めた対応経験（TOEIC700点以上目安）
・ 製薬企業やCDMOでの業務経験
・ マネジメント経験
・TOEIC700点以上が望ましい

【免許・資格】

【勤務開始日】

応相談

勤務地

【住所】大阪

年収・給与

750万円～1000万円　

内資製薬メーカーにて海外事業会計や税務の担当をお願いします。

仕事内容

具体的には、中期計画の策定、予算策定、予実管理・分析、内部統制強化、会計・税務関連を中心とした海外子会社における課題解決等、海外子会社の経営陣と連携し、業績目標達成、ガバナンス強化等に取り組んでいただきます。また、Ｍ＆Ａのプロジェクトにおいて、初期的な評価（バリュエーション）、デューデリジェンスの実施、ディールの推進、ＰＭＩプロジェクトの推進等を担っていただきます。上記以外にも、海外事業部門のマネジメント全般における諸課題に対して、自ら提案しスピード感をもって推進いただくことが期待されます。

応募条件

【必須事項】

＜経験＞
・事業会社における 会計または税務実務経験（5年以上）
・海外子会社管理、または国際税務に関わる実務経験
＜能力＞
・管理会計全般（予算策定、予実管理、財務分析等）
・高いコミュニケーション能力およびリーダーシップ
・分析力、課題設定力および問題解決能力
・英語での実務遂行能力（目安：TOEIC 800点以上、ビジネスレベル）

【歓迎経験】

＜経験＞
・クロスボーダーM&A、移転価格税制対応の経験
・ヘルスケア事業会社での経験
・多国籍環境での業務経験
＜能力＞
・公認会計士、税理士、USCPAなどの資格保持者
・IFRSや海外会計基準の知識

【免許・資格】

【勤務開始日】

応相談

勤務地

【住所】東京

年収・給与

600万円～1000万円　経験により応相談

既存顧客および新規顧客からの引き合い対応、事業部との調整および共同での提案など担当いただきます。

仕事内容

・企業・バイオベンチャー・アカデミアからの治験・製販後調査・臨床研究における様々なフェーズ、多種多様な業務が経験できます
・治験・製販後調査・臨床研究分野における臨床試験システム、EDC、ePROなど、最先端のITサービス業務に関われます
・事業部全体を俯瞰し、ベストな提案を考えることができます
・新規サービスへのチャレンジや提案の機会も多々あります

応募条件

【必須事項】

・臨床開発や医薬開発・研究分野に関する興味関心
いずれか必須
・CRO、SMO等での営業経験または臨床研究や臨床開発業務経験
・法人/アカデミア向けの大型商材(※)の営業経験3年以上(※例:産業/工作機械・基幹システム等の顧客側で予算申請/調整が必要な商材)

【歓迎経験】

・新しいことに興味があり、チャレンジを厭わない方
・様々な立場の関係者にバランスよく配慮ができる方
・チームワークを重視される方
・海外での営業経験もしくは英語を使用してのビジネス経験

【免許・資格】

【勤務開始日】

応相談

勤務地

【住所】在宅可、東京、他

年収・給与

450万円～650万円　経験により応相談

内資製薬メーカーにて医薬品原材料の購買・調達担当を募集しています。

仕事内容

今回は新規製品開発を支える原料調達および製造委託先の選定をお任せします。開発や製造部門、社外のパートナーとも連携強化しながら、調達業務を推進していただきます。品質とコストの両面を追求しつつ、新規サプライヤーの開拓・評価、価格交渉、契約締結、製造委託先の選定・管理を通じて、安定供給とサプライチェーンリスク管理を推進していただきます。開発部門や製造部門と密に連携し、社内外のパートナーシップを強化することで、調達業務を推進していただきます。将来的には、調達体制のさらなる強化と事業成長への貢献を期待しています。

・新規製品開発や生産に必要な原材料および製造委託先の選定・開拓
・サプライヤーとの価格交渉、契約締結、および関係性構築
・製造委託先の品質・納期・コスト管理と改善活動の推進
・サプライチェーンリスクの特定と対策の立案・実行
・原材料の市場動向調査と調達戦略の策定
・社内関連部署（開発・生産・品質など）との連携・調整
・調達業務における法務・コンプライアンス遵守の推進

応募条件

【必須事項】

・製造業での調達・購買実務経験3年以上
・新規サプライヤー開拓・評価の実務経験
・価格交渉と契約締結の実務経験
・製造委託先の選定・管理の実務経験
・製品品質管理に関する基礎知識
・原材料の市場動向分析能力
・契約法務・コンプライアンスに関する知識

【歓迎経験】

・新規サプライヤー開拓・評価の実績
・品質管理体制の構築または改善経験
・サプライチェーンリスク管理の実践経験
・ERPシステム導入・運用改善への参画経験
・原材料の市場動向分析に基づく戦略策定経験
・海外サプライヤーとの取引・交渉実務経験
・サプライチェーンリスク管理の知識

【免許・資格】

【勤務開始日】

応相談

勤務地

【住所】東京

年収・給与

600万円～1000万円　

内資製薬メーカーにて製品開発を支える原材料グローバル調達をお任せします。

仕事内容

新規製品開発や生産に不可欠な原材料のグローバル調達・購買業務全般をお任せします。世界中のサプライヤーと連携し、品質、コスト、納期を最適化した原材料の安定供給を実現することが重要なミッションです。具体的には、新規サプライヤーの開拓、価格交渉、契約締結、納期管理など、多岐にわたる業務を推進していただきます。ビジネスレベルの英語力を活かし、海外サプライヤーとの円滑なコミュニケーションを通じて良好な関係を構築し、サプライチェーン全体の最適化に貢献いただきます。また、変化の激しい市場環境において、自ら課題を発見し、解決策を提案することで、新規製品開発の成功と事業成長に不可欠な役割を担っていただくことを期待します。

・新規製品開発や生産に必要な原材料のグローバル調達の推進
・国内外サプライヤーの新規開拓、選定、評価、価格交渉、契約締結
・調達原材料の納期・品質・コスト管理とサプライヤーとの関係構築
・グローバル市場における原材料の動向調査と情報収集、分析
・開発部門や生産部門など社内外関係者との連携・調整業務
・調達プロセスの改善提案、コスト削減、効率化の推進
・サプライチェーンにおけるリスク管理と対応策の検討・実施

応募条件

【必須事項】

・原材料のグローバル調達・購買実務経験3年以上
・ビジネスレベルの英語力
・海外サプライヤーとの交渉・取引実務経験
・国際的なサプライチェーンに関する基礎知識
・新規製品開発における調達業務の経験
・コスト削減目標達成に向けた交渉力
・発注・納期管理に関する実務経験

【歓迎経験】

・貿易実務検定C級以上の資格
・中国語など英語以外のビジネス語学力
・ERP/SCMシステム導入・運用経験
・コスト削減やサプライヤー開拓の実績
・法務・契約に関する基礎知識
・データ分析ツールを用いた業務改善経験

【免許・資格】

【勤務開始日】

応相談

勤務地

【住所】東京

年収・給与

600万円～1000万円　

内資製薬メーカーにて貿易実務担当をお任せします。

仕事内容

・輸入業務、通関、関税手続きの管理と国際法規遵守
・医薬品・食品分野のサプライチェーン最適化と効率化を推進
・SCM・貿易業務の改善・運用（SAPシステムを用いる）
・業務改善・DX戦略推進（RPA、AI等のデジタル技術を活用）

応募条件

【必須事項】

・医薬品または食品分野での実務経験
・ERPシステム（SAP等）の運用経験
・輸入業務、通関、関税に関する実務経験
・デジタル技術を活用した業務改善推進経験

【歓迎経験】

・国際法規や貿易協定に関する深い知識
・プロジェクトのマネジメント経験
・デジタル技術を活用した業務改善経験
・国際貿易における通関・関税の実務経験
・SCMにおけるデータ分析・最適化経験

【免許・資格】

【勤務開始日】

応相談

勤務地

【住所】東京

年収・給与

600万円～1000万円　

国内大手CDMOにて注射剤設計を行っていただきます。

仕事内容

•注射剤の製剤設計・製造法開発：無菌製剤の特性を踏まえた処方設計やスケールアップ検討等を担当。
•治験薬・安定性試験用製剤の供給：開発ステージに応じた製剤をタイムリーに提供。
•申請関連業務（IND/NDA）：規制当局への申請資料作成や照会対応。
•技術移管：製造部門や外部委託先へのスムーズな移管を推進。

応募条件

【必須事項】

・注射剤等の無菌製剤開発の経験(5年以上)
・大卒(理系全般)、高専卒（理系全般）
・英語メール等で業務を遂行できるレベルの方（TOEICスコア700点以上、あるいは同等の英語力のある方が望ましい）

【歓迎経験】

・薬剤学、物理化学、工学系の専門技術・知見を有している方歓迎

【免許・資格】

【勤務開始日】

応相談

勤務地

【住所】大阪

年収・給与

500万円～700万円　経験により応相談

固形製剤及びバイオ医薬品における品質管理業務全般をお任せします。

仕事内容

・医薬品、治験薬の試験責任者もしくは試験担当者(リーダー)として、医薬品に対する品質管理面の業務を担うと共にPJ業務のマネジメント、チーム員への業務多能化などを品質管理責任者と共に業務推進していただきます。

応募条件

【必須事項】

・試験責任者又は試験担当者(リーダー)として分析業務の経験がある方
・医薬品製造に関するガイドラインの理解(GMP)
・固形製剤又はバイオ医薬品(無菌製剤)の知識を有する方

【歓迎経験】

・国内外の査察対応経験のある方
・組織マネジメントや人材育成の経験又は興味のある方
・機器分析の知識を有している方
・英語能力（英語文書の作成、海外サイトとのメールや会議でのコミュニケーションに興味のある方）
・再生医療、細胞試験業務に従事もしくは興味がある方
・コンピューターシステム関連業務に従事もしくは興味がある方(品質管理システムLIMS等)

【免許・資格】

【勤務開始日】

応相談

勤務地

【住所】静岡

年収・給与

600万円～　経験により応相談

同社グループの従業員、ご家族への健康管理や健康づくりにおける支援を担当いただきます。

仕事内容

・各種健診（定期健診・特定健診・精密検診・女性検診・歯科健診）
・保健指導、重症化予防事業などの国のデータヘルス計画にかかる保健事業の推進
・事業主の健康経営の推進事業や健康づくり事業（コラボヘルス）の推進
・健診にかかるデータや基幹システムの運用管理
・上記および部門全般にかかる事務業務全般（人事・経理・総務・広報・法務）

応募条件

【必須事項】

・健診、保健指導等の国のデータヘルス計画にかかる保健事業や、事業主の健康経営や健康づくり事業（コラボヘルス）などの業務経験
・Officeの操作スキル

【歓迎経験】

・人事総務などバックオフィス業務の経験

【免許・資格】

【勤務開始日】

応相談

勤務地

【住所】在宅可、大阪

年収・給与

500万円～1000万円　

大手内資製薬メーカーにて臨床試験リーダーを求めています。

仕事内容

（雇入れ直後）
• Manage and lead the day-to-day operations of assigned trials to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements
• Manage and lead cross-functional trial teams, including vendor set-up, performance oversight and closeout activities
• Responsible for oversight and guidance to clinical study team members in completing deliverables according to agreed timelines and quality standards, including awareness and escalation of high impact quality-related topics for assigned studies
• Ensure set-up and implementation of effective investigator and site monitor training; coordinate operational and therapeutic area training for internal and external trial team members
• Lead or oversee development of core study documents, study plans and systems set-up to ensure operational excellence in execution of the clinical trial protocol and quality across investigative sites, vendors and data
• Proactively identify and resolve issues that arise during trial conduct; manage escalation of trial-related issues, internally and externally
• Provide input on clinical operational/development matters for interactions with regulatory authorities and key opinion leaders, either globally or regionally
• Lead preparation of vendor requirements and assess vendor capabilities to support trial scope and selection of qualified vendors; effectively manage interactions with vendor project management team
• Lead feasibility assessment and selection of countries and sites for trial conduct
• Facilitates site engagement and communications with investigators and/or staff to support study milestones and deliverables
• Participates in and/or facilitates cross-functional collaboration and strategic problem solving to ensure risk mitigation, appropriate progress and timely completion of trials and deliverables according to established objectives, milestones and goals
• Provide accurate and up-to-date trial information in relevant tracking systems and provide regular updates of trial progression to the Clinical Operations Lead and other defined stakeholders
• Participates in inspection readiness activities including coordination of clinical study team deliverables
• Individuals may serve in regional capacity to represent Clinical Operations in submissions and interactions with Health Authorities or other (external) activities as applicable
• Individuals may provide regional clinical strategies directly or indirectly to asset team, in collaboration with clinical operations lead, to optimize global development strategy
• Facilitate and manage regional KOL interactions, as applicable
• Oversee the clinical aspects of timely data cleaning, data analysis and the availability of top line results; support development of data review plans, review of statistical analysis plans and participate in data reviews and manage data findings
• Participate in process improvement and quality-related initiatives associated with trial execution and deliverables; participate in establishment of best-in-class processes and standards for trial conduct
• Provide oversight and direction to trial team members for trial deliverables, including ensuring the evaluation and implementation of patient-focused strategies for assigned trials, globally and regionally, as appropriate
• Responsible for the preparation and management of budgets, timelines and resources for assigned clinical trials

応募条件

【必須事項】

・BA/BS degree with at least 3 years clinical trial experience or direct equivalent experience or advanced degree (MS/PhD/PharmD) with at least 2 years clinical trial experience.
・Must have strong knowledge of ICH/GCP guidelines and regulatory requirements.
・Must have knowledge of protocol and clinical drug development processes, clinical trial design, trial planning and management, and monitoring.
・Requires project management skills and trial leadership ability.
・Must have excellent interpersonal, written, and verbal communication skills, administrative skills and computer ability.
・Fluent in English
・Moderate (~25%) travel required

【歓迎経験】

・Advanced Degree

【免許・資格】

【勤務開始日】

応相談

勤務地

【住所】在宅可、東京

年収・給与

700万円～　経験により応相談

大手内資製薬メーカーにて臨床モニター（CRA）のスタディマネージャーを募集しています。

仕事内容

・Supports the day-to-day operations of assigned trials and responsibilities to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements.
・Responsible for maintaining accurate and up-to-date trial information within relevant tracking systems and provide regular updates as requested to trial team and other defined stakeholders.
・Participates in or lead trial related systems set-up including implementation and maintenance of appropriate systems, standards, and processes to ensure quality across investigative sites, vendors and data.
・Participates in CRO and vendor set-up and management during clinical trial execution, as requested by clinical trial lead and/or clinical team.
・Participates in or facilitates site engagement and communications with investigators and/or staff to support trial milestones and deliverables.
・Participates in CRO and vendor set-up and management during clinical trial execution, as requested by clinical trial lead and/or clinical team.
・Ensures quality and completeness of TMF for assigned clinical trials.

応募条件

【必須事項】

・BA/BS degree with at least 3 years clinical trial experience or direct equivalent experience or advanced degree (MS/PhD/PharmD) with at least 2 years clinical trial experience.
・Must have strong knowledge of ICH/GCP guidelines and regulatory requirements.
・Must have knowledge of protocol and clinical drug development processes, clinical trial design, trial planning and management, and monitoring.
・Requires project management skills and trial leadership ability.
・Must have excellent interpersonal, written, and verbal communication skills, administrative skills and computer ability.
・Fluent in English
・Moderate (~25%) travel required

【歓迎経験】

・Advanced Degree

【免許・資格】

【勤務開始日】

応相談

勤務地

【住所】在宅可、東京

年収・給与

700万円～　経験により応相談

大手内資製薬メーカーにて臨床試験マネージャーを求めています。

仕事内容

（雇入れ直後）
• Manage the day-to-day operations of assigned trials and responsibilities to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements.
• Leads or supports cross-functional trial teams, including vendors.
• Ensures accurate and up-to-date trial information within relevant tracking systems and provide regular updates of trial progression to Clinical Operations Lead, Clinical Trial Lead, and other defined stakeholders.
• Proactively identify and resolve issues that arise during trial conduct; manage escalation of trial-related issues.
• Participate in or lead the development of core trial documents, trial plans and system set-up; participate in preparation and ensure operational excellence of protocol and implementation of appropriate systems, standards, and processes to ensure quality across investigative sites, vendors, and data.
• Participate in or lead preparation of vendor requirements and project scope and selection of trial vendors; effectively manage interactions and escalations with vendor trial team.
• Participate in or lead feasibility assessment and selection of countries and sites for trial conduct.
• Participate in or facilitates site engagement and communications with investigators and/or staff to support trial milestones and deliverables.
• Oversee the clinical aspects of timely data cleaning, data analysis and the availability of top line results; participate in data reviews and review of statistical analysis plans.
• Participate in or lead set-up and implementation of effective investigator and site monitor training; coordinate operational and therapeutic area training for internal and external trial team members.
• Provide oversight and direction to trial team members for trial deliverables.
• Manage clinical trial budget and associated vendor contracts, including tracking and data in associated systems.
• Ensure quality and completeness of TMF for assigned clinical trials.
• Participates in inspection readiness activities including coordination of clinical trial team deliverables.
• Participate in the evaluation and implementation of patient-focused strategies for assigned trials, as applicable.
• Responsible for the management of budgets, timelines and resources for assigned clinical trial responsibilities.

応募条件

【必須事項】

• BA/BS degree with at least 3 years clinical trial experience or direct equivalent experience or advanced degree (MS/PhD/PharmD) with at least 2 years clinical trial experience.
• Must have strong knowledge of ICH/GCP guidelines and regulatory requirements.
• Must have knowledge of protocol and clinical drug development processes, clinical trial design, trial planning and management, and monitoring.
• Requires project management skills and trial leadership ability.
• Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability.
• Fluent in English.
• Moderate (~25%) travel required.

【歓迎経験】

・Advanced Degree

【免許・資格】

【勤務開始日】

応相談

勤務地

【住所】在宅可、東京

年収・給与

700万円～　経験により応相談